Mgr Quality Systems Data Integrity & Validation (MedTech)

Location: Leiden, Netherlands

Base pay: €68,600–€119,600 per year

Company

Johnson & Johnson MedTech develops healthcare solutions and medical technologies, with this role supporting Janssen Biologics in a regulated GxP environment.

What you will do

• Provide Quality oversight for site Data Integrity, Data Governance, and computerized systems programs.
• Lead data integrity assessments, data risk assessments, process-flow mapping, audit trail review strategies, and remediation plans.
• Review and approve validation lifecycle documentation for GxP computerized systems, equipment, instruments, and digital tools.
• Ensure systems remain validated and controlled across their lifecycle, including access controls, interfaces, data migration, backup and restore, security, and archival.
• Lead or oversee system improvements, automation, digitalisation, and modernization initiatives with appropriate compliance and change controls.
• Support audits and regulatory inspections while coaching stakeholders and driving cross-functional compliance actions.

Requirements

• Bachelor’s or Master’s degree in a scientific, pharmaceutical, engineering, quality, automation, IT, or related discipline.
• Significant experience in a pharmaceutical, biotechnology, medical device, or other regulated GxP environment.
• Strong experience in Quality Assurance, Quality Systems, computerized systems validation, Data Integrity, compliance, or related technical Quality functions.
• Knowledge of EU GMP Annex 11, 21 CFR Part 11, GAMP 5, GMP requirements, and Quality Risk Management principles.
• Experience with validation lifecycle management, system controls, data governance, audit trail review, inspections, audits, and remediation programs.
• Fluent English is required. Strong analytical, communication, stakeholder management, documentation, and independent decision-making skills are expected.

Nice to have

• Experience with site-level Data Integrity or Data Governance programs.
• Experience with digital transformation, automation, AI-enabled systems, electronic Quality Systems, or system modernization in a GxP environment.
• Experience with Lean, Process Excellence, project management, or mentoring Quality and technical professionals.

Culture & Benefits

• Inclusive work environment based on individual respect, diversity, and accountability.
• Annual bonus with a target based on pay grade and location, subject to performance.
• Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Recognition awards and access to insurance plans subject to applicable terms and location.